目的 觀察小兒風熱清合劑治療急性上呼吸道感染（風熱感冒證）患兒的有效性及安全性。方法 采用隨機、雙盲雙模擬、陽性藥物平行對照、多中心臨床試驗設計，納入14個臨床評價中心共240例患兒，利用區(qū)組隨機法分為試驗組120例和陽性藥物對照組120例，試驗組給予小兒風熱清合劑及小兒寶泰康顆粒模擬劑，對照組給予小兒寶泰康顆粒及小兒風熱清合劑模擬劑，療程均為5 d，用藥滿72 h后臨床痊愈者，隨時停藥，按完成病例處理。采用全分析數據集（FAS）、符合方案數據集（PPS）與安全數據集（SS）分析，評價兩組患兒主要癥狀（發(fā)熱、鼻塞、流濁涕、咽紅腫痛、咳嗽）的消失時間、完全退熱時間、即時退熱時間、中醫(yī)證候積分及單項癥狀積分變化情況，并進行安全性評價。結果 FAS分析顯示：試驗組中位主要癥狀消失時間為67.50 h、對照組為69.00 h，中位完全退熱時間兩組均為46.00 h；中位即時退熱時間兩組均為4.00 h；用藥5 d后，試驗組有效率為99.12%、對照組有效率為95.69%，上述4個指標兩組比較差異無統(tǒng)計學意義；治療3 d，試驗組患兒鼻塞及咽紅腫痛的臨床痊愈率高于對照組（P<0.05），兩組患兒不良事件發(fā)生比較差異無統(tǒng)計學意義；試驗期間均未見不良反應發(fā)生。結論 小兒風熱清合劑治療急性上呼吸道感染療效較好，在改善鼻咽部癥狀方面優(yōu)于小兒寶泰康顆粒，且安全性好。

Objective To evaluate the curative effect and safety of Xiaoer Fengreqing Mixture in treating Acute Upper Respiratory Infection (anemopyretic cold) in Children. Methods A multicenter randomized, double-blind, double-dummy, positive drug parallel control clinical trial was designed. A total of 240 children in 14 centers were divided into the test group of 120 cases and the positive control group of 120 cases with randomized-block method. The test group was given Xiaoer Fengreqing Mixture and Xiaoer Baotaikang Granules simulant; while the control group was given Xiaoer Baotaikang Granules and Xiaoer Fengreqing Mixture simulant. The course in both groups was 5 days. Patients clinically cured can stop medication after treating for 72 h, which was processed as the completed case. Using full analysis set (FAS), per-protocol set (PPS) and safety set (SS) analysis, the two groups of children were evaluated for the disappearance time of the main symptoms (fever, nasal congestion, runny nose, pharyngeal swelling and pain, cough), complete antipyretic time, immediate antipyretic time, Traditional Chinese Medicine (TCM) syndrome score and individual symptom score changes, and safety evaluation. Results In FAS, the median disappearance time of the main symptoms was 67.50 h in the test group, and 69.00 h in the control group. The median time for complete antipyretic time were 46.00 h in both groups. The median immediate antipyretic time was four hour in both groups. After 5 days of treatment, the effective rate of the test group was 99.12%, and the effective rate of the control group was 95.69%. There was no statistically significant difference between the two groups in the above four indicators (P>0.05). After three days of treatment, the clinical recovery rate of nasal congestion and pharyngeal swelling and pain in the test group was higher than that in the control group (P<0.05). There was no significant difference in the occurrence of adverse events between the two groups of children; there was no side effect during the experiment. Conclusion Xiaoer Fengreqing Mixture has a good effect in treating acute upper respiratory tract infection, and is better than Xiaoer Baotaikang Granules in improving nasopharyngeal symptoms, and has good safety.

R287.5

國家衛(wèi)計委藥政司“中藥兒童用藥相關政策建議”課題示范項目（zyxhekkt014）